BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUS 2000

    MDR report key: 96354 · Received June 2, 1997

    Report

    Report Number
    2914019-1997-00018
    Event Type
    Malfunction
    Date Received
    June 2, 1997
    Date of Event
    May 1, 1997
    Report Date
    June 2, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN EVALUATING THE FILTER THAT WAS OUT OF SPECIFICATION CO HAS DETERMINED THAT THE WATTS DELIVERED DID NOT CAUSE LIGHT IN EXCESS OF 21 CFR 1040 CLASS 1 CRITERIA. THEREFORE, IT IS EXTREMELY UNLIKELY ANY INJURY OCCURRED WHILE USING THE LASER.

    Description of Event or Problem · 1

    DOCTOR REPORTED FLASHBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS 2000 LDS-20 LASER DELIVERY SYSTEM GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other